InfluenzaPhase 3NCT00959049

A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population

A Phase 3 study testing CSL's Influenza Virus Vaccine (Afluria) and Influenza Virus Vaccine (Fluzone) in people with Influenza, run by Seqirus at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years. Read more about this study

Who is it for?: Ages 6 months to 17 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: CSL's Influenza Virus Vaccine (Afluria) and Influenza Virus Vaccine (Fluzone)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,474 participants
Where: 23 sitesUnited States
Study dates: Sep 2009to May 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy male or non-pregnant female participants aged ≥ 6 calendar months to < 18 years at the time of the first study vaccination.
For participants aged ≥ 6 months to < 9 years, born after a normal gestation period (between 36 and 42 weeks).
Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment.

Who cannot join

Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Study site
Bardstown, Kentucky, 40004
Study site
Binghamton, New York, 13901
Study site
Burke, Virginia, 22015
Study site
Chandler, Arizona, 85224
Cincinnati Children's Hospital Medical Center- Division of Infectious Disease
Cincinnati, Ohio, 45229
Study site
Elmira, New York, 14901
UPMC / Community Medicine Inc
Greenville, Pennsylvania, 16125
Study site
Harrisburg, Arkansas, 72432
Study site
Jonesboro, Arkansas, 72401
Pediatric Associates of Latrobe
Latrobe, Pennsylvania, 15650
Study site
Little Rock, Arkansas, 72205
Study site
Melbourne, Florida, 32935
Study site
Mountain Home, Arkansas, 72653
Study site
Omaha, Nebraska, 68134
Pediatric Alliance Greentree Division
Pittsburgh, Pennsylvania, 15220
South Hills Pediatrics
Pittsburgh, Pennsylvania, 15227
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Salt Lake City, Utah, 84109
Study site
Salt Lake City, Utah, 84121
Study site
Salt Lake City, Utah, 84124
Study site
South Jordan, Utah, 84095
Study site
Vienna, Virginia, 22180
Study site
Warr Acres, Oklahoma, 73132

Other trials in United States

About this study

Official title: A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.

Conditions: Influenza
Being tested: CSL's Influenza Virus Vaccine (Afluria), Influenza Virus Vaccine (Fluzone)
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CSL's Influenza Virus Vaccine (Afluria)Biological
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Influenza Virus Vaccine (Fluzone)Biological
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines

Study groups in NCT00959049
Study group	Role	What they receive
Afluria Cohort A	Experimental	Age 6 months to < 3 years Receives: Biological: CSL's Influenza Virus Vaccine (Afluria)
Afluria Cohort B	Experimental	Age 3 to < 9 years Receives: Biological: CSL's Influenza Virus Vaccine (Afluria)
Afluria Cohort C	Experimental	Age 9 to < 18 years Receives: Biological: CSL's Influenza Virus Vaccine (Afluria)
Fluzone Cohort A	Active comparator	Age 6 months to < 3 years Receives: Biological: Influenza Virus Vaccine (Fluzone)
Fluzone Cohort B	Active comparator	Age 3 to < 9 years Receives: Biological: Influenza Virus Vaccine (Fluzone)
Fluzone Cohort C	Active comparator	Age 9 to < 18 years Receives: Biological: Influenza Virus Vaccine (Fluzone)

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric Mean Titer 30 Days After the Last Study Vaccination
Measured: 30 days after the last study vaccination
Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination
Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
Measured: 30 days after the last study vaccination

Secondary outcomes (9)

Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Measured: 7 days after each vaccination
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Measured: 7 days after each vaccination
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Measured: 7 days after vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
UAE stands for Unsolicited Adverse Events
Measured: 30 days after each vaccination
New Onset of Chronic Illnesses (NOCIs)
New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).
Measured: 6 months after last study vaccination
Serious Adverse Events (SAEs)
Measured: 6 months after last study vaccination
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Measured: 7 days after each vaccination
Duration of Local and Systemic Solicited Symptoms, Cohort B
Measured: 7 days after each vaccination
Duration of Local and Systemic Solicited Symptoms, Cohort C
Measured: 7 days after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009May 2010

First posted14 Aug 2009 (estimated)
Study startSep 2009
Primary completionDec 2009
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,474 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00959049
Sponsor's protocol ID: CSLCT-USF-07-36
Status last verified: Apr 2017
First submitted: 12 Aug 2009
Last updated: 16 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Brady RC, Hu W, Houchin VG, Eder FS, Jackson KC, Hartel GF, Sawlwin DC, Albano FR, Greenberg M. Randomized trial to compare the safety and immunogenicity of CSL Limited's 2009 trivalent inactivated influenza vaccine to an established vaccine in United States children. Vaccine. 2014 Dec 12;32(52):7141-7. doi: 10.1016/j.vaccine.2014.10.024. Epub 2014 Oct 29.
PubMed 25454878

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.
ClinicalTrials.gov ID: NCT00959049
Acronym / sponsor ID: CSLCT-USF-07-36
Conditions: Influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,474 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Dec 2009 (actual)
Study completion: May 2010 (actual)
First posted: 14 Aug 2009 (estimated)
Results: Posted 29 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Afluria Cohort A	Experimental	Biological: CSL's Influenza Virus Vaccine (Afluria)Age 6 months to < 3 years
Afluria Cohort B	Experimental	Biological: CSL's Influenza Virus Vaccine (Afluria)Age 3 to < 9 years
Afluria Cohort C	Experimental	Biological: CSL's Influenza Virus Vaccine (Afluria)Age 9 to < 18 years
Fluzone Cohort A	Active comparator	Biological: Influenza Virus Vaccine (Fluzone)Age 6 months to < 3 years
Fluzone Cohort B	Active comparator	Biological: Influenza Virus Vaccine (Fluzone)Age 3 to < 9 years
Fluzone Cohort C	Active comparator	Biological: Influenza Virus Vaccine (Fluzone)Age 9 to < 18 years

Who may qualify

Ages: 6 months to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Healthy male or non-pregnant female participants aged ≥ 6 calendar months to < 18 years at the time of the first study vaccination.
For participants aged ≥ 6 months to < 9 years, born after a normal gestation period (between 36 and 42 weeks).
Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment.

Key exclusion criteria (1 listed)

Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CSL's Influenza Virus Vaccine (Afluria)0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines	Biological	Afluria Cohort A, Afluria Cohort B, Afluria Cohort C
Influenza Virus Vaccine (Fluzone)0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines	Biological	Fluzone Cohort A, Fluzone Cohort B, Fluzone Cohort C

Primary outcome

Geometric Mean Titer 30 Days After the Last Study Vaccination
Time frame: 30 days after the last study vaccination
Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination
Time frame: 30 days after the last study vaccination
Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.

9 secondary outcomes

Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Time frame: 7 days after each vaccination
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Time frame: 7 days after each vaccination
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Time frame: 7 days after vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Time frame: 30 days after each vaccination
New Onset of Chronic Illnesses (NOCIs)
Time frame: 6 months after last study vaccination
Serious Adverse Events (SAEs)
Time frame: 6 months after last study vaccination
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Time frame: 7 days after each vaccination
Duration of Local and Systemic Solicited Symptoms, Cohort B
Time frame: 7 days after each vaccination
Duration of Local and Systemic Solicited Symptoms, Cohort C
Time frame: 7 days after vaccination

Results and safety

Results posted to the registry on 29 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Afluria Cohort A	231	213
Afluria Cohort B	254	247
Afluria Cohort C	254	253
Fluzone Cohort A	228	217
Fluzone Cohort B	257	248
Fluzone Cohort C	250	249

Primary outcome: Geometric Mean Titer 30 Days After the Last Study Vaccination

Time frame: 30 days after the last study vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Afluria Cohort A n = 195	Afluria Cohort B n = 229	Afluria Cohort C n = 230	Fluzone Cohort A n = 201	Fluzone Cohort B n = 236	Fluzone Cohort C n = 233
H1N1 (A/Brisbane/59/2007)	235.44 (199.67 to 277.61)	345.50 (295.54 to 403.92)	652.99 (566.91 to 752.14)	227.19 (188.39 to 273.98)	351.88 (303.29 to 408.25)	652.17 (569.59 to 746.73)
H3N2 ( A/Uruguay/716/2007)	309.19 (253.49 to 377.13)	909.22 (772.67 to 1069.90)	948.86 (824.88 to 1091.46)	340.49 (283.98 to 408.25)	870.34 (751.62 to 1007.80)	1069.7 (934.77 to 1224.11)
B (B/Brisbane/60/2008)	73.46 (59.32 to 90.97)	122.71 (102.55 to 146.83)	107.92 (71.77 to 126.91)	57.92 (46.92 to 71.49)	104.91 (88.67 to 123.42)	126.99 (107.53 to 149.97)

Population analysed: Per-protocol population

Primary outcome: Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination

Time frame: 30 days after the last study vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Afluria Cohort A n = 195	Afluria Cohort B n = 229	Afluria Cohort C n = 230	Fluzone Cohort A n = 201	Fluzone Cohort B n = 236	Fluzone Cohort C n = 233
H1N1 (A/Brisbane/59/2007)	84 (78 to 89)	66 (59 to 72)	64 (57 to 70)	74 (67 to 80)	64 (58 to 70)	61 (55 to 68)
H3N2 ( A/Uruguay/716/2007)	83 (77 to 88)	71 (65 to 77)	72 (66 to 78)	85 (79 to 90)	74 (68 to 80)	73 (66 to 78)
B (B/Brisbane/60/2008)	67 (60 to 73)	73 (67 to 79)	67 (31 to 73)	61 (54 to 68)	76 (70 to 82)	73 (67 to 79)

Population analysed: Per-Protocol Population

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected for 180 days after the last study vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Afluria Cohort A	4 of 229 (1.7%)	210 of 231 (90.9%)	Not reported
Afluria Cohort B	3 of 252 (1.2%)	216 of 254 (85%)	Not reported
Afluria Cohort C	2 of 254 (0.8%)	214 of 254 (84.3%)	Not reported
Fluzone Cohort A	4 of 228 (1.8%)	187 of 228 (82%)	Not reported
Fluzone Cohort B	0 of 255 (0%)	202 of 257 (78.6%)	Not reported
Fluzone Cohort C	0 of 250 (0%)	202 of 250 (80.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25454878Brady RC, Hu W, Houchin VG, Eder FS, Jackson KC, Hartel GF, Sawlwin DC, Albano FR, Greenberg M. Randomized trial to compare the safety and immunogenicity of CSL Limited's 2009 trivalent inactivated influenza vaccine to an established vaccine in United States children. Vaccine. 2014 Dec 12;32(52):7141-7. doi: 10.1016/j.vaccine.2014.10.024. Epub 2014 Oct 29.

Related trials for Influenza

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Director Vaccines study director

Seqirus

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CSL's Influenza Virus Vaccine (Afluria) and Influenza Virus Vaccine (Fluzone) in people with Influenza, run by Seqirus at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titer 30 Days After the Last Study Vaccination (time frame: 30 days after the last study vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00959049, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.